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1. Ivacaftor - Lumacaftor
2. Ivacaftor, Lumacaftor Drug Combination
3. Lumacaftor, Ivacaftor Drug Combination
1. Lumacaftor / Ivacaftor
2. Lumacaftor And Ivacaftor
3. Lumacaftor And Ivacaftor Tablet
4. Schembl19410545
5. Vx 700-vx 809 Combination
6. Vx 809-vx 770 Combination
7. Ivacaftor Mixture With Lumacaftor
8. Lumacaftor, Ivacaftor Drug Combination
9. S900006790
10. 1815566-23-4
| Molecular Weight | 844.9 g/mol |
|---|---|
| Molecular Formula | C48H46F2N4O8 |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 9 |
| Exact Mass | 844.32837076 g/mol |
| Monoisotopic Mass | 844.32837076 g/mol |
| Topological Polar Surface Area | 176 Ų |
| Heavy Atom Count | 62 |
| Formal Charge | 0 |
| Complexity | 1450 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 1 | |
|---|---|
| Drug Name | ORKAMBI |
| Active Ingredient | IVACAFTOR; LUMACAFTOR |
| Company | VERTEX PHARMS INC (Application Number: N206038. Patents: 7495103, 7973038, 8324242, 8410274, 8507534, 8653103, 8716338, 8741933, 8754224, 8846718, 8993600, 9150552, 9192606, 9216969, 9670163, 9931334) |
Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.
Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene.
R07AX30
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ABOUT THIS PAGE
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PharmaCompass offers a list of Orkambi API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Orkambi manufacturer or Orkambi supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Orkambi manufacturer or Orkambi supplier.
PharmaCompass also assists you with knowing the Orkambi API Price utilized in the formulation of products. Orkambi API Price is not always fixed or binding as the Orkambi Price is obtained through a variety of data sources. The Orkambi Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lumacaftor and ivacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumacaftor and ivacaftor, including repackagers and relabelers. The FDA regulates Lumacaftor and ivacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumacaftor and ivacaftor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lumacaftor and ivacaftor supplier is an individual or a company that provides Lumacaftor and ivacaftor active pharmaceutical ingredient (API) or Lumacaftor and ivacaftor finished formulations upon request. The Lumacaftor and ivacaftor suppliers may include Lumacaftor and ivacaftor API manufacturers, exporters, distributors and traders.
Lumacaftor and ivacaftor Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Lumacaftor and ivacaftor GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Lumacaftor and ivacaftor GMP manufacturer or Lumacaftor and ivacaftor GMP API supplier for your needs.
A Lumacaftor and ivacaftor CoA (Certificate of Analysis) is a formal document that attests to Lumacaftor and ivacaftor's compliance with Lumacaftor and ivacaftor specifications and serves as a tool for batch-level quality control.
Lumacaftor and ivacaftor CoA mostly includes findings from lab analyses of a specific batch. For each Lumacaftor and ivacaftor CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Lumacaftor and ivacaftor may be tested according to a variety of international standards, such as European Pharmacopoeia (Lumacaftor and ivacaftor EP), Lumacaftor and ivacaftor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lumacaftor and ivacaftor USP).
